Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT06325956
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2024-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PCOS Immune Function Predicts Metformin Efficacy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.', 'timeFrame': 'Samples to be collected once per participant within 7 days of enrollment.', 'description': 'Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.'}, {'measure': 'The percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.', 'timeFrame': 'Samples to be collected once per participant within 7 days of enrollment.', 'description': 'Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and the fluorescently labeled antibody in human peripheral blood, and the unlabeled cells were dissolved.'}], 'secondaryOutcomes': [{'measure': 'Homeostasis model assessment of insulin resistance', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'insulin resistance index'}, {'measure': 'body mass index', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'body mass index (kg/m2)'}, {'measure': 'menstrual frequency', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'number of menstruation in a year'}, {'measure': 'fasting glucose', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'fasting glucose (mmol/L)'}, {'measure': 'fasting insulin', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'fasting insulin (mmol/L)'}, {'measure': 'Total cholesterol', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Total cholesterol (mmol/L)'}, {'measure': 'Triglycerides', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Triglycerides (mmol/L)'}, {'measure': 'HDL-c', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'HDL-c (mmol/L)'}, {'measure': 'LDL-c', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'LDL-c (mmol/L)'}, {'measure': 'total testosterone', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'total testosterone (nmol/L)'}, {'measure': 'free testosterone', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'free testosterone (nmol/L)'}, {'measure': 'Sex hormone-binding globulin', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Sex hormone-binding globulin (nmol/L)'}, {'measure': 'Androstenedione', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Androstenedione (ng/ml)'}, {'measure': 'Dehydroepiandrosterone', 'timeFrame': 'Within 7 days of enrollment.', 'description': 'Dehydroepiandrosterone (ug/dl)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Metformin', 'Immune Function']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will include PCOS patients who meet the trial criteria, introduce participants to the content of this study, and invite participants to participate. The immune function of peripheral blood samples of PCOS patients was detected by flow cytometry. Participants were further treated with metformin for 6 months and followed up after the intervention. The objective of this study was to investigate immune markers related to the efficacy of metformin in PCOS patients and to predict the efficacy of metformin in PCOS patients using immune function.', 'detailedDescription': 'In this study, peripheral blood samples of PCOS patients were collected before and after intervention. Flow cytometry was used to detect the antigenic antibody reaction between the surface differentiation antigen of lymphocyte membrane and fluorescently labeled antibodies in human peripheral blood, and the unlabeled cells were dissolved. The number and percentage of cell groups expressing different markers were counted by the fluorescence detection system on flow cytometry.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 18-45 years\n* Diagnosis of PCOS with the Rotterdam diagnosis criteria (2003)\n\nExclusion Criteria:\n\n* Pregnant women;\n* Hyperthyroidism or hypothyroidism\n* Severe liver and kidney function injury\n* Cancer patients;\n* Associated with severe infection, severe anemia, neutropenia and other blood system diseases;\n* Have type 1 diabetes, single-gene mutated diabetes or other secondary diabetes;\n* Patients with mental illness or intellectual disability;\n* Have taken drugs for PCOS treatment in the last three months;\n* Have a long history of taking hormone therapy;\n* Currently or recently participating in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT06325956', 'briefTitle': 'PCOS Immune Function Predicts Metformin Efficacy', 'organization': {'class': 'OTHER', 'fullName': "Shanghai 10th People's Hospital"}, 'officialTitle': 'Prediction of Immune Status on the Efficacy of Metformin in the Treatment of Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'Immune status and metformin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metformin therapy', 'description': 'Metformin intervention, 1000mg daily for the first week, 1500mg daily starting in the second week until six months of treatment.', 'interventionNames': ['Drug: Metformin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Metformin therapy'], 'description': 'Take metformin for six months.', 'armGroupLabels': ['Metformin therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200072', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Manna Zhang, Doctor', 'role': 'CONTACT', 'email': 'mannazhang@126.com', 'phone': '86-21-66301004'}], 'facility': "Department of Endocrinology, Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Manna Zhang, doctor', 'role': 'CONTACT', 'email': 'mannazhang@126.com', 'phone': '+8613774448495'}], 'overallOfficials': [{'name': 'Manna Zhang, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Shanghai 10th People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Zhang Manna', 'investigatorAffiliation': "Shanghai 10th People's Hospital"}}}}